MADRID--(BUSINESS WIRE)--Sep. 29, 2014--
AVEO Oncology (NASDAQ:AVEO) and Biodesix, Inc. today announced the
presentation of results from a retrospective exploratory analysis using
VeriStrat®, a commercially available serum protein test, to identify
patients most likely to benefit from the addition of ficlatuzumab,
AVEO’s HGF inhibitory antibody, to epidermal growth factor receptor
(EGFR) tyrosine-kinase inhibitor (TKI) therapy in a randomized Phase 2
study of ficlatuzumab and gefitinib (IRESSA®) in previously untreated
Asian subjects with non-small cell lung cancer (NSCLC). The results,
presented in a poster session (abstract #8195) at the 2014 Congress of
the European Society for Medical Oncology (ESMO), suggest that VeriStrat
may be selective of positive clinical response for ficlatuzumab plus
gefitinib over gefitinib alone.

“EGFR TKIs are an important class of therapy for which VeriStrat has
potential prognostic and predictive value,” said Tony Mok, M.D.,
Professor, Department of Clinical Oncology, The Chinese University of
Hong Kong, and senior investigator of the study. “VeriStrat appears to
measure a host response in which tumors may become stimulated by
alternative pathways, such as HGF/c-MET, leading to resistance to EGFR
TKI therapy. In this exploratory analysis, the addition of the
HGF-targeted antibody ficlatuzumab to an EGFR TKI therapy has shown
encouraging results in this subgroup, including significant improvements
in overall survival and progression free survival.”

Exploratory Analysis Results in Detail

A total of 188 patients were enrolled in a randomized Phase 2 study
(P6162) designed to compare the combination of ficlatuzumab and
gefitinib with gefitinib alone in treatment-naïve Asian patients with
non-small cell lung adenocarcinoma. For this retrospective exploratory
analysis, 180 serum samples were assigned a VeriStrat label of either
“Good” (VSG) or “Poor” (VSP) (VSG=145, VSP=35). While the study failed
to demonstrate improved overall survival (OS) or progression-free
survival (PFS) over gefitinib alone in the intent-to-treat population,
the addition of ficlatuzumab to gefitinib provided significant clinical
benefit to the VSP subgroup:

VSP

ficlatuzumab andgefitinib

n=18

gefitinib alone

n=17

OS

Median

23.9 months

5.8 months

Hazard Ratio

0.41

p-value

0.032

PFS

Median

7.4 months

2.3 months

Hazard Ratio

0.41

p-value

0.014

No benefit was observed in the VSG subgroup in either OS (Median 24.7 mo
for ficlatuzumab + gefitinib [n=69] vs not reached for gefitinib alone
[n=76]; HR 1.18, p=0.492) or PFS (Median 5.6 mo for ficlatuzumab +
gefitinib vs 5.6 mo for gefitinib alone; HR 1.06, p=0.753). Despite the
small sample sizes, similar patterns in OS and PFS based on VeriStrat
stratification were also observed in patients with known EGFR mutations
(n=71) and VSP classification (n=11):

VSP and EGFRm

ficlatuzumab andgefitinib

n=5

gefitinib alone

n=6

OS

Median

17.8 months

10.4 months

Hazard Ratio

0.3

p-value

0.09

PFS

Median

11.1 months

2.3 months

Hazard Ratio

<0.01

p-value

<0.01

Based on these data, in April 2014, AVEO and Biodesix® entered into a
worldwide agreement to develop and commercialize ficlatuzumab with a
Biodesixcompanion diagnostic test. As part of this
agreement, AVEO and Biodesix plan to conduct a confirmatory Phase 2
study using a Biodesix VeriStrat “Poor” classification as a selective
biomarker for the combination of ficlatuzumab and an EGFR-TKI, versus an
EGFR TKI alone, in previously untreated, EGFR mutation-positive patients
with advanced non-small-cell lung cancer. The study is expected to
initiate before year-end.

“This analysis suggests that VeriStrat Poor, EGFR TKI-sensitizing
mutation-positive patients with NSCLC appear to have limited response to
EGFR TKI alone, identifying a significant unmet medical need,” stated
Tuan Ha-Ngoc, president and chief executive officer of AVEO. “Given our
scientific hypothesis, and the encouraging results in this well-defined
patient subset, we believe further clinical evaluation of ficlatuzumab
and an EGFR TKI therapy in this population is warranted.”

“These results suggest that a blood test may be used to more precisely
classify the response of a subset of patients who, based on EGFR
mutation status, should be candidates for an EGFR inhibitor yet appear
not to respond to the mono-therapy without the addition of
ficlatuzumab,” said David Brunel, chief executive officer of Biodesix.
“By using biomarkers and Biodesix’ proprietary ‘predictive intelligence’
computational approach, we believe we can further identify patient
sub-populations with differential predictive and prognostic outcomes to
advance decisions for therapeutic guidance. Biomarkers are empowering
oncologists and the healthcare community with an evidence-based medical
approach that informs more precise decisions on diagnosis, prognosis,
therapeutic guidance and quality of patient care.”

HGF is the sole ligand that binds to and activates a receptor called
c-Met. Activation of the HGF/c-Met pathway is believed to be important
in normal processes in embryonic development and wound healing, but its
dysregulation is believed to play a role in cancer development,
metastasis and drug resistance. HGF/c-Met has also been shown to be one
of the most potent drivers of tumor growth in AVEO’s Human Response
Platform™.

HGF/c-Met over-expression is observed in many solid tumors including
breast, colorectal, gastric, head and neck, lung and prostate, as well
as hematologic malignancies. Additionally, c-Met and EGFR are frequently
co-amplified and co-expressed in a variety of tumor types; HGF/c-Met
pathway upregulation can render resistance to EGFR-targeted therapies,
and vice-versa. HGF has also been shown to be one of the most potent
growth factors that can drive resistance to a panel of anti-cancer
therapies.

Ficlatuzumab is a humanized IgG1κ antibody that binds to the HGF ligand
with high affinity and specificity to inhibit the biological activities
of the HGF/c-Met pathway. Studies have demonstrated that ficlatuzumab is
well tolerated as a single agent as well as in combination with EGFR
TKIs.

About VeriStrat

VeriStrat, developed by Biodesix, is a multivariate, blood-based,
protein test currently available to help physicians guide treatment
decisions for patients with advanced non-small cell lung cancer. The
test identifies patients who are likely to have “Good” or “Poor”
outcomes after treatment with either epidermal growth factor receptor
tyrosine kinase inhibitor (EGFR-TKI) therapy such as erlotinib or with
chemotherapy. VeriStrat is based on Biodesix’ proprietary proteomics
platform which enables the discovery of multivariate classifiers that
characterize a patient’s condition or likely outcome in response to
therapy. www.VeriStratSupport.com.

About AVEO

AVEO Oncology (NASDAQ:AVEO) is a biopharmaceutical company committed to
discovering and developing targeted therapies designed to provide
substantial impact in the lives of people with cancer by addressing
unmet medical needs. AVEO’s proprietary Human Response Platform™
provides the company unique insights into cancer and related disease
biology and is being leveraged in the discovery and clinical development
of its therapeutic candidates. For more information, please visit the
company’s website at www.aveooncology.com.

About Biodesix

Biodesix is a molecular diagnostics company advancing the development of
innovative products for personalizing medicine. The company provides
physicians with diagnostic tests for earlier disease detection, more
accurate diagnosis, disease monitoring and better therapeutic guidance,
which may lead to improved patient outcomes. Biodesix discovers,
develops and commercializes multivariate protein diagnostics based on
their proprietary mass spectrometry-based discovery platform. In
addition to developing novel diagnostics independently, the company also
partners with biotechnology and pharmaceutical companies to develop
companion diagnostics to improve utility of therapeutic agents. For more
information about Biodesix, please visit www.Biodesix.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO within
the meaning of The Private Securities Litigation Reform Act of 1995 that
involve substantial risks and uncertainties. All statements, other than
statements of historical facts, contained in this press release are
forward-looking statements. The words “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “may,” “plan,” “target,” “potential,”
“could,” “should,” “seek,” or the negative of these terms or other
similar expressions, are intended to identify forward-looking
statements, although not all forward-looking statements contain these
identifying words. These forward-looking statements include, among
others, statements about AVEO’s plans to conduct a Phase 2 study of
ficlatuzumab using Biodesix’s Veristrat test; the commencement of the
Phase 2 study prior to year-end; Veristrat’s prognostic value and the
ability for VeriStrat to be predictive of positive clinical response for
ficlatuzumab plus gefitinib over gefitinib alone. Actual results or
events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements that AVEO makes
due to a number of important factors, including risks relating to:
AVEO’s ability to execute on its business strategy and enter into and
maintain new strategic partnerships and collaboration agreements; AVEO’s
ability to successfully enroll and complete clinical trials and
preclinical studies of its product candidates; AVEO’s ability to
demonstrate to the satisfaction of the FDA, or equivalent foreign
regulatory agencies, the safety, efficacy and clinically meaningful
benefit of its product candidates; AVEO’s ability to achieve and
maintain compliance with all regulatory requirements applicable to its
product candidates; AVEO’s ability to obtain and maintain adequate
protection for intellectual property rights relating to its product
candidates and technologies; developments and expenses related to AVEO’s
ongoing shareholder litigation and SEC inquiry; AVEO’s ability to raise
the substantial additional funds required to achieve its goals; adverse
general economic and industry conditions; competitive factors; and those
risks discussed in the section titled “Risk Factors” included in AVEO’s
most recent Quarterly Report on Form 10-Q and in its other filings with
the SEC. The forward-looking statements in this press release represent
AVEO’s views as of the date of this press release. AVEO anticipates that
subsequent events and developments will cause its views to change.
However, while AVEO may elect to update these forward-looking statements
at some point in the future, it specifically disclaims any obligation to
do so. You should, therefore, not rely on these forward-looking
statements as representing AVEO’s views as of any date subsequent to the
date of this press release.